Package Insert: Information for the Patient

Cefixima Normon 400 mg Hard Capsules EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Cefixima Normon contains a medicine called cefixima, which belongs to the group of antibiotics known as “cephalosporins”, which are used to treat infections caused by bacteria.

Cefixima Normon is used to treat

• Acute sinusitis
• Middle ear infection
• Infection causing sudden worsening of a long-standing bronchitis
• Uncomplicated acute urinary tract infection
• Uncomplicated kidney infection

Do not take Cefixima Normon

• if you are allergic to cefixima or to any of the other components of this medication (listed in section 6),
• if you are allergic to any other type of cephalosporin antibiotic,
• if you have had a severe allergic reaction to penicillin or any other type of beta-lactam antibiotic.

Do not take this medication if you meet any of the above criteria. If you are unsure, consult your doctor or pharmacist before taking cefixima.

Warnings and precautions

Consult your doctor or pharmacist before starting to take cefixima:

• if you have had colitis at any time
• if you have kidney problems
• if the person taking this medication is under 12 years of age

If you are unsure whether the above applies to you, consult your doctor or pharmacist before taking this medication.

Cefixima is not suitable for everyone.

Before taking cefixima, tell your doctor:

• if you are allergic to penicillin or any other beta-lactam antibiotic.

An allergic reaction may include skin rash (hives), itching, difficulty swallowing or breathing, or swelling of the face, lips, throat, and tongue. Not everyone who is allergic to penicillins is also allergic to cephalosporins. However, you should be especially cautious if you have ever had a reaction to any penicillin, as you may also be allergic to this medication.

If a patient experiences a severe allergic reaction or anaphylaxis (a severe allergic reaction that causes difficulty breathing or dizziness) after administration of cefixima, administration will be discontinued and appropriate treatment will be provided.

• if you are taking other medications that are harmful to the kidneys. Also inform your doctor if you have any kidney problems. Your doctor may perform certain tests periodically to measure kidney function during treatment.

• if you have had intense or persistent diarrhea with stomach pain or cramps during treatment with cefixima or afterwards, stop taking this medication and contact your doctor immediately. You will not be able to take medications that slow down or stop intestinal movement.

If you experience a syndrome known as DRESS (skin rash with eosinophilia and systemic symptoms), Stevens-Johnson syndrome, or a skin reaction known as toxic epidermal necrolysis (see section 4. Possible adverse reactions) while taking cefixima, stop taking this medication and contact your doctor immediately.

Treatment with a cycle of cefixima may temporarily increase the likelihood of infections caused by other types of germs that cefixima does not act on. For example, you may experience oral candidiasis (infection caused by a levaduriform fungus called Candida).

Other medications and Cefixima Normon

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

In particular, inform your doctor or pharmacist if you are taking:

• medications that damage the kidneys such as
• antibiotics such as aminoglycosides, colistin, polymyxin, and viomicin
• diuretics, such as etacrynic acid or furosemide, which increase the amount of urine your body produces
• nifedipine, a medication used to treat high blood pressure or heart problems
• anticoagulants (medications that prevent blood clotting) such as warfarin in some patients. Cefixima causes blood clotting problems and may increase the time it takes for blood to clot
• oral contraceptives

Effect on laboratory tests

If you have blood or urine tests, inform your doctor that you are taking cefixima, as cefixima may alter the results of some of these tests.

Cefixima may alter the results of some sugar tests in urine (such as Benedict's or Fehling's tests). If you have diabetes and have periodic urine tests, inform your doctor, as it may be necessary to use other tests to control diabetes while taking this medication.

Cefixima may alter the results of some tests to measure ketones in urine. Inform your doctor that you are taking cefixima, as it may be necessary to use other tests.

Cefixima may alter the results of a blood test to detect antibodies called the direct Coombs test.

Taking Cefixima Normon with food and drinks

Cefixima can be taken with or without food. The capsule should be swallowed with a glass of water.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication. Always consult your doctor or pharmacist before taking any medication.

Driving and operating machinery

Cefixima usually does not affect the ability to drive and operate machinery.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. The dose prescribed by your doctor will depend on the type of infection and its severity. It also depends on kidney function. Your doctor or pharmacist will explain this to you.

The recommended dose is:

Adults

The recommended dose in adults is 400 mg (1 Cefixima Normon 400 mg capsule or 2 Cefixima Normon 200 mg capsules) per day as a single oral dose, or divided into two equal doses of 200 mg (1 Cefixima Normon 200 mg capsule) every 12 hours. The medication should be taken at the same time every day.

Patients with kidney problems

In patients with kidney problems, it may be necessary to reduce the dose of cefixima. Your doctor will calculate the correct dose for you based on the results of blood or urine tests that measure kidney function.

The available data on the use of cefixima in children and adolescents with kidney problems are insufficient. Therefore, it is not recommended to use cefixima in these patients.

Older adults

No adjustment of the dose is necessary for older adults if kidney function is normal.

Adolescents 12 years of age and older

Adolescents 12 years of age and older can receive the same dose as adults.

Children under 12 years of age

The capsule formulation is not suitable for children under 12 years of age.

If you take more Cefixima Normon than you should

Consult your doctor or pharmacist.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service (Tel. 91 562 04 20), indicating the medication and the amount ingested.

If you forget to take Cefixima Normon

If you forget to take a capsule, take it as soon as you remember. However, if there are less than 6 hours until the next dose, do not take it and resume the usual schedule. Do not take a double dose to compensate for missed doses.

If you interrupt treatment with Cefixima Normon

It is essential to take this medication until the end of the prescribed cycle. Do not stop taking cefixima simply because you feel better. If you stop taking it too soon, the infection may recur. If the person receiving treatment continues to feel unwell at the end of the prescribed treatment cycle or worsens during treatment, inform your doctor.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Most are considered mild and transient.

The following side effects are serious and require immediate action if you experience them. Stop taking cefixima and seek immediate medical attention if you experience the following symptoms:

Very rare (may affect up to 1 in 10,000 people):

• Severe watery diarrhea that may also be bloody

• Intense allergic reactions (anaphylactic shock) such as skin rash, itching, swelling of the face, lips, tongue, or other parts of the body, feeling of tightness in the chest, wheezing, or fainting.

• Severe skin disease with blisters on the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome, toxic epidermal necrolysis) (see section 2. What you need to know before taking Cefixima Normon - Warnings and precautions).

Frequency not known (cannot be estimated from available data):

• Intense skin rash, fever, lymph node enlargement, increase in a type of white blood cell called eosinophils (DRESS syndrome) (see section 2. What you need to know before taking Cefixima Normon - Warnings and precautions).

The following side effects have also been reported:

Frequent(may affect up to 1 in 10 people):

• Diarrea

Infrequent(may affect up to 1 in 100 people):

• Headache
• Nausea
• Vomiting
• Abdominal pain (in the stomach)
• Changes in blood tests that measure liver function
• Skin rash

Rare(may affect up to 1 in 1,000 people):

• Increased risk of infection by germs that cefixima does not act on, for example, oral candidiasis.
• Increased number of a type of white blood cell called eosinophils
• Allergic reaction
• Loss of appetite
• Dizziness
• Flatulence (gas)
• Itching skin
• Inflammation of the mucous membrane that lines the mouth or other internal surfaces
• Fever
• Changes in blood tests that measure kidney function

Very rare(may affect up to 1 in 10,000 people):

• Reduction in the number of various blood cells (symptoms may include fatigue, new infections, and propensity to bruise or bleed)
• Allergic reaction characterized by skin rash, fever, joint pain, and enlargement of certain organs
• Restlessness and increased activity
• Liver problems, such as jaundice (yellowing of the skin or white of the eyes)
• Kidney inflammation

Frequency not known(cannot be estimated from available data):

• Increased number of platelets (thrombocytosis)
• Reduction in the number of a type of white blood cell (neutropenia)
• Indigestion

- Skin rash or skin lesions with a ring of pink/red color and a pale center, which may itch, peel, or be filled with fluid. The rash appears especially on the palms of the hands or soles of the feet. They may be signs of a severe allergy to the medicine, called "erythema multiforme".

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaRAM.es/. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C. Store in the original packaging.

Medications should not be disposed of through drains or in the trash. Dispose of containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Cefixima Normon

• The active ingredient is cefixima. A capsule contains 400 mg of cefixima (as trihydrate).
• The other components (excipients) are: Anhydrous colloidal silica, macrogol stearate 40, and magnesium stearate. Components of the capsule: gelatin, yellow iron oxide (E-172), and titanium dioxide (E-171).

Appearance of the product and contents of the packaging

Cefixima Normon 400 mg are hard, yellow opaque capsules that are packaged in PVC/Aluminum blisters and are presented in packs of 1 and 10 hard capsules.

Only some pack sizes may be commercially available

Holder of the marketing authorization and responsible manufacturer

Normon Laboratories, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos— Madrid

Spain

Last review date of this leaflet:October / 2016

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)